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Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd.,...

FDA Recall #D-0002-2026 — Class II — September 24, 2025

Recall #D-0002-2026 Date: September 24, 2025 Classification: Class II Status: Ongoing

Product Description

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Reason for Recall

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Recalling Firm

Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

600 30-count bottles

Distribution

Distributed Nationwide in the USA

Code Information

Lot#: E409309, Exp 12/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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